Warning letter: Failure to validate (ucm337808)

Failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system, as required by 21 CFR 820.70(i). For example, your firm uses custom automatic machines in the needle production process. Your firm stated that it performed software validation for the automatic machines and that the software protocol was tested, but these validation activities were not documented.